Dr. John Noble completes 10-year FDA study of Hip Resurfacing Device
Lake Charles, LA (KPLC) - A local doctor has recently helped complete a 10-year FDA landmark study regarding a Hip Resurfacing Device.
John Noble, Jr. MD, orthopaedic surgeon with the Center for Orthopaedics, was one of five principal investigators in the U.S. Food and Drug Administration’s (FDA) post-approval, 10-year study of the Birmingham Hip Resurfacing (BHR) procedure.
Along with the other participating surgeons, he co-authored a report of the study’s results recently published in The Journal of Bone & Joint Surgery-American, the most highly regarded journal for orthopedic surgeons globally.
The FDA approved BHR procedures in the United States in 2006 without the usually stringent pre-approval requirements for clinical outcome studies.
The FDA made this rare exception to the usual approval process based on overwhelming data from Europe and Australia demonstrating outstanding results of the procedure. The procedure was approved so patients in the U.S. would not have to wait for the new technology. However, the regulatory agency required a post-approval clinical study to determine if the same favorable outcomes would be duplicated in the U.S.
According to Dr. Noble, the 10-year study was able to confirm this.
As one of the first surgeons in the U.S. to perform BHR, Dr. Noble was selected to participate in the multi-center clinical outcomes study.
Dr. Noble says, “The four other sites chosen were universities. We were the only community site. We each enrolled roughly 50 patients and tracked their progress for ten years. The patients who did best were men under 55, who wanted to remain active and did not have a metal allergy. A metal analysis test can now be done to determine the presence of a metal allergy. We didn’t have reliable testing at the beginning of the study.”
He continues, “I am pleased to report that the results of our 10-year study demonstrated that BHR has a 96% survivorship of the implant at 10 years’ post-procedure, with particularly successful results in younger, active male patients. This procedure gives us an ideal solution for those patients with hip pain who would be considered too young and active for a traditional hip replacement.”
Dr. Noble explained that rather than replacing the entire hip joint, as in a total hip replacement, BHR is a bone-conserving approach that preserves more of the patient’s natural bone structures.
The all-metal implant resembles a cap on a tooth more closely than a hip implant, “This approach reduces the post-operative risks of dislocation and inaccurate leg length. The implant is made from tough, smooth cobalt chrome and has the potential to last longer than traditional hip implants, which is why we are so excited about the results in younger patients. I’ve found that my BHR patients have experienced significant improvement in their overall quality of life, and they can remain very active if required by their occupation.”
However, not every patient needing a hip replacement is a candidate for BHR.
Dr. Noble says the procedure is best suited for male patients under age 55 who suffer from hip pain due to osteoarthritis or dysplasia. In such cases, total hip replacement may not be appropriate due to their increased level of physical activity.
Dr. Noble generally reserved this operation for law enforcement, firefighters, or individuals who have a strong desire to remain active.
He adds that the surgery has better results for men than women because of the difference in femoral head size. “The ideal combination between socket size and head size works better with men because of the clearance in between. This clearance allows just enough joint fluid that the head can move without friction.”
For more information about hip replacement and BHR, you can call (337) 721-7236 to schedule an appointment with Dr. Noble.
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